Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 September 1983 to 26 September 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to acceptable standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Pale yellow liquid labelled:­ Reolube TM 10

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Healthy New Zealand White rabbits were used. These were aged 12-14 weeks with average body weights of 2.19 kgs (male) and 2.15 kgs. (female) and were obtained from a commercial supplier (Hacking and Churchill) Six rabbits (3 and 3 )were acclimatized in the test area for one week prior to the start of the trial.

Husbandry
The rabbits were caged singly in an experimental room maintained at a temperature of 16°C (± 1°) and a relative humidity of 50 - 70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial diet (Labsure, Christopher Hill Group)was fed ad lib. Filtered water acidified to approximately pH 3 was available at all times.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL test substance was applied
Duration of treatment / exposure:
24 hours
Observation period:
14 days or until any effects had resolved
Number of animals:
6
Details on study design:
Twenty four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum, but not to damage the dermis. The left hand site remained intact.

0.5 ml of the compound as supplied was applied to each test site on a 2.5 cm square gauze pad. These were covered with aluminium foil secured with "Transpore" surgical tape. The test sites were then covered by a 6" wide "Coban"-self adhesive bandage in order to retain the testsubstance in close contact with the skin. After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours and for any further period considered necessary up to 14 days.

The assessment of the macroscopic skin reaction was made according to the following grading system:

Primary Irritation Score

0: Non irritating
0.1- 0.5: Minimally irritating
0.6 - 1.5: Slightly irritating
1.6 - 3.0: Mildly irritating
3.1- 5.0: Moderately irritating
5.1 - 6.5: Severely irritating
6.6 - 8.0: Extremely irritating





Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin. No assessment done at 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
mean
Time point:
other: At 24 hours and at 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin. No assessment done at 48 hours.
Irritant / corrosive response data:
24 hours
Slight/well defined erythema was seen:on 3/6 intact and 4/6 abraded sites. Very slight oedema was seen on 5/6 intact and 4/6 abraded sites. Slight oedema was seen on one abraded site.

72 hours
Very slight oedema was seen on 3/6 intact and abraded sites.

6 days

All sites were normal.


The reactions were similar on intact and abraded sites. The primary irritation score was 1.1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the results of an in vivo study in New Zealand White rabbits, the test substance was not classified as a skin irritant.
Executive summary:

According to the results of an in vivo study in New Zealand White rabbits, the test substance was not classified as a skin irritant.

The mean oedema score and the mean erythema score for each of the 6 rabbits at 24 hours and at 72 hours was less than or equal to 1. All effects were fully reversible within 6 days.